BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2223890 · Received August 18, 2011

    Report

    Report Number
    3002037047-2011-00054
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE SAMPLE FOR EVALUATION OR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ABNORMALITIES WERE NOTED. REVIEW OF THE COMPOSITION OF THE ITEMS SHOWED THAT THE CUSTOM PAK LOT CONTAINS NO ITEMS THAT HAVE POLYMETHLMETHACRYLAAT (PMMA) AS MATERIAL CONSTRUCTION. THE PRODUCT WAS BUILT AND RELEASED ACCORDING TO MANUFACTURER'S SPECIFICATION. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A LEAD PRACTITIONER REPORTED THAT FOREIGN BODIES WERE FOUND IN THE EYES OF TWO PTS DURING SURGICAL PROCEDURES. FOR THIS PT, THE FOREIGN BODY WAS DESCRIBED AS CLEAR, HARD MATERIAL LIKE "PERSPEX", NOT BRITTLE LIKE GLASS. THE FOREIGN BODIES WERE LIKE MICROSCOPIC CRYSTALLIZED ATOMS SEEN PRIOR TO PHACO PROCEDURE WHILE USING THE IRRIGATION SETTING ON THE CONSOLE. THE PT WAS TREATED INTRAOPERATIVELY WITH ADDITIONAL ANTIBIOTICS, AND THE EYE WAS FLUSHED WITH A SALINE SOLUTION USING THE HANDPIECE. THE SAME SALINE SOLUTION BAGS WERE USED FOR BOTH PTS AND UNSPECIFIED DOSES OF ADRENALIN WERE ADDED USING UNFILTERED NEEDLES. THE SAME LOT NUMBER OF VISCOELASTIC WAS USED IN BOTH PTS, BUT THE REPORTER DOES NOT BELIEVE THE FOREIGN MATERIAL IS RELATED SINCE THIS WAS USED AFTER THE FOREIGN MATERIAL WAS DISCOVERED. THE PT OUTCOME WAS REPORTED AS GOOD. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS; THIS REPORT IS FOR THE FIRST PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V. CUSTOM PAK 299431

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention HEALON| BALANCED SALT SOLUTION| LIDOCAINE 1%| INFINITI VISION SYSTEM OZIL| INTRACAMERAL CEFUROXIME| OZIL TORSIONAL PHACO HANDPIECE| BASIC PACK